Parasym tVNS Скачать руководство пользователя страница 6

 
 

POTENTIAL RISKS AND COMPLICATIONS 

 

The Parasym device is considered low risk when used in accordance with the instructions for use. A low

 

 

   

 

 

 

 

   

 

 

 

 

 

   

 

incidence of skin irritation has been reported from using the Parasym device. No serious adverse events

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

have been reported. If you experience any side effects from device use stop treatment immediately. If in

 

 

   

 

 

 

 

 

 

 

 

 

 

     

doubt, contact your healthcare provider.  
 
A 2018 systematic review analysed 1322 participants (across 51 studies) who received transcutaneous

 

 

 

 

 

 

 

 

 

 

 

 

 

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vagus nerve stimulation. NOTE: this review analysed studies using multiple different tVNS methodologies

 

 

 

 

 

 

 

 

 

 

 

 

 

so the results cannot be extrapolated to the Parasym device and are included only as reference

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

information for tVNS.  
 
The review found that only only 2.6% of participants discontinued use due to side effects, where the most

 

 

 

 

 

 

   

 

 

 

   

 

 

 

 

 

common side effect reported was skin irritation at the stimulation site which typically ceased shortly after

 

 

 

 

 

 

   

 

 

 

 

 

 

 

 

use.   
 
The following side effects were reported in this review with use of transcutaneous vagus nerve stimulation

 

 

 

 

 

   

 

 

 

   

 

 

 

 

devices: 
 
Tingling/pain/redness/itching at the site of electrode placement during long term application (16.7%) 
Lightheadedness/dizziness (1.4%) 
Fatigue (0.5%) 
Shortness of breath (0.4%) 
Voice alteration/hoarseness (0.3%) 
Abnormal heart rhythm (0.3%) 

 

 
IF IN DOUBT CONSULT YOUR DOCTOR OR HCP. 

 
 

Environmental Conditions: 
 

Temperature : 

Operating: 5 ~ 40 

 

Storage : -25 ~ 70 

 

R.H.ambient : 

Operating: 15% ~ 93% RH 
Storage : 0% ~ 93% RH 

Altitude : 

Operating: 700hPa to 1060hPA 
Storage : 500hPa to 1060hPA 

 

 
 

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Redgrave, J., Day, D., Leung, H., Laud, P. J., Ali, A., Lindert, R., & Majid, A. (2018). Safety and 

tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain stimulation, 
11(6), 1225-1238.

 

Содержание tVNS

Страница 1: ...Parasym tVNS Device Quick Start Guide...

Страница 2: ...1...

Страница 3: ...for you that you can use every day Two AA alkaline batteries are included so you can start straight away Before using your device please make sure you have read all the precautions warnings and safet...

Страница 4: ...the electrodes and accessories recommended by the manufacturer as using others may be unsafe Any electrodes that have current densities exceeding 2 mA cm 2 may require special attention of the operato...

Страница 5: ...or cracked The device casing is cracked dented or appears to be damaged Discontinue use if you experience Lightheadedness dizziness or chest pain Excessive skin irritation Caring for Your Device Do no...

Страница 6: ...6 of participants discontinued use due to side effects where the most common side effect reported was skin irritation at the stimulation site which typically ceased shortly after use The following si...

Страница 7: ...Instructions For Use 6...

Страница 8: ...7...

Страница 9: ...Electrode Placement Connect the electrode to the tragus of the left ear running the cable behind the neck over the right shoulder 8...

Страница 10: ...9...

Страница 11: ...into channel 1 3 Electrode Placement 3 1 Clip the electrode to your left tragus See diagram on Page 8 Make sure this is a good connection with both gold plates having a firm contact with the skin 4 Pu...

Страница 12: ...s of use per day This can be achieved by pressing the timer button to 60 min The device will automatically shut down after 60 minutes Please find a convenient time each day using the treatment at the...

Страница 13: ...ception turn the device off then turn the device on and repeat this step to find a lower intensity Note If no stimulation is felt at Level 36 apply a small amount of moisture to the tragus and repeat...

Страница 14: ...r treatment session should be one level below the sensory level where it can be perceived or felt For most people this is between Level 1 Level 15 however some people need to go to the maximum to find...

Страница 15: ...ectedly This is likely to be the power save function If no buttons are pressed and the intensity level is zero the unit will power off automatically after a few minutes There is no stimulus simulation...

Страница 16: ...Visit our Help Center Our Help Centre has answers to most common questions You can access this at www parasym co hc 15...

Страница 17: ...ort team Reach out to us via our support messaging widget on our website www parasym co and we ll get right back to you You can also email us directly at hello parasym co and this will also go through...

Страница 18: ...mmerse the device in water 4 Do not use any other cleaning solution than soap and water Testing the Device The device can be tested by making sure the batteries are in the device correctly pressing th...

Страница 19: ...s shown in the image on page 8 Note the safety and efficacy of the Parasym device has not been established in individuals with Implantable medical devices a history of cardiac disease or arrhythmia di...

Страница 20: ...ctangular Mode 5 Modes are available Mode A Constant Stimulation Mode B Burst I Two train per second 250ms on 250ms off 25 pulses within one train pulse width 200 S Mode C Burst II Two train per secon...

Страница 21: ...ects on the environment Symbols Explanation Type BF Applied Part Refer to Instructions for Use Compliance with WEEE regulations Manufacturer European Representative IP22 Protected against access to ha...

Страница 22: ...Version 4 2 www parasym co 21...

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